A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate 20 Mcg/0.5 mL in the Treatment of Patients With COPD

NCT ID: NCT00280371

Last Updated: 2010-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-05-31

Brief Summary

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The purpose of this study is to determine the safety and efficacy of the investigational drug in comparison with a placebo.

Detailed Description

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Conditions

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COPD

Keywords

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COPD Chronic Obstructive Pulmonary Disease formoterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Formoterol Fumarate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Medical diagnosis of COPD
* Current or prior history of cigarette smoking

Exclusion Criteria

* Medical diagnosis of asthma
* Chest X-ray diagnostic of significant disease other than COPD
* Significant condition or disease other than COPD
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dey

INDUSTRY

Sponsor Role lead

Responsible Party

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Dey

Locations

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Jasper, Alabama, United States

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Phoenix, Arizona, United States

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Buena Park, California, United States

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Costa Mesa, California, United States

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Huntington Beach, California, United States

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Long Beach, California, United States

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San Diego, California, United States

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Stockton, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Wheat Ridge, Colorado, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Miami Beach, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Coeur d'Alene, Idaho, United States

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Hines, Illinois, United States

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Normal, Illinois, United States

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Overland Park, Kansas, United States

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Shawnee Mission, Kansas, United States

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Topeka, Kansas, United States

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North Dartmouth, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Henderson, Nevada, United States

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Summit, New Jersey, United States

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Camillus, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Elizabeth City, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Upland, Pennsylvania, United States

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Cranston, Rhode Island, United States

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Spartanburg, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Waco, Texas, United States

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South Burlington, Vermont, United States

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Abingdon, Virginia, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

Other Identifiers

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201-069

Identifier Type: -

Identifier Source: org_study_id